Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Biofer S.p.A. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Italy
Founded:2001
Employees:356
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Europe
Manufacturing Facilities
1 site worldwide
Biofer, SpA
Via Canina 2, Medolla, MO, 41036
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
16
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval Q0NE8D
PMDA · #APR-PC48DDZH · 2019-12-01
Drug Approval H1ZPWN
Health Canada · #APR-AF69CSZH · 2018-04-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-MXIHAFVC
Issued: 2020-09-07
Expires: 2025-12-12
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-O4UQHR6L
Issued: 2020-12-25
Expires: 2025-08-06
WHO GMP
World Health Organization
Cert #: CERT-B7SYO5B3
Issued: 2020-10-27
Expires: 2025-06-21
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-MYM0BZC9
Issued: 2020-04-24
Expires: 2025-07-23
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Key facts about Biofer S.p.A.
- Biofer S.p.A. is headquartered in Italy.
- Biofer S.p.A. was founded in 2001.
- Biofer S.p.A. has 356 employees.
- Biofer S.p.A. has one manufacturing site listed on CDMO Hub, in Medolla, Italy.
- Biofer S.p.A.'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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